Asynchronous Techniques for the Delivery of Empirically Supported Psychotherapies

Not Applicable

Completed

• Conditions: Anxiety; Stress; Impairment; Depressive Symptoms
• Interventions: Behavioral: e-Health Treatment

• Registration Number: NCT05122429
• Lead Sponsor: Stony Brook University

Brief Summary

The aim of this study is to test the feasibility, acceptability and efficacy of methods for delivering mental health support when real-time communication is not possible (e.g. on long duration space flights where communication lags of up to 45 minutes are anticipated). The investigators hypothesize that the two enhanced treatment conditions (i.e., those with therapist support) will outperform the online self-management program without support. The investigators also predict that outcomes for the two enhanced conditions will be comparable to those reported in the literature for in-person psychotherapy programs.

Detailed Description

The aim of this study is to test the feasibility, acceptability and efficacy of methods for delivering mental health support when real-time communication is not possible (e.g. on long duration space flights where communication lags of up to 45 minutes are anticipated). Participants will be healthy, high functioning adults (e.g., medical residents, postdoctoral fellows in the sciences, math, and engineering) who report elevated psychological distress, mood or anxiety symptoms. Participants will complete a self-guided online therapy program (MyCompass) and will be randomized to receive one of the following: (1) online therapy without therapist support, 2) online therapy plus therapist support via electronic text-based messaging (i.e., secure email), or 3) online therapy plus therapist support via video messaging. Outcomes will be evaluated weekly via online self-report measures of psychological distress, mood, anxiety, number of hours and quality of sleep, fatigue, and resiliency indicators (i.e., coping and mindfulness). The investigators will examine changes over time in outcomes across all three groups. The investigators hypothesize that the two enhanced treatment conditions (i.e., those with therapist support) will outperform the online self-management program without support. The investigators also predict that outcomes for the two enhanced conditions will be comparable to those reported in the literature for in-person psychotherapy programs.

Study Timeline

• Study Start: 2017-11-06
• Primary Completion: 2018-12-17
• Study Completion: 2018-12-17
• Study First Submitted: 2021-10-18
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-04
• Last Update Submitted: 2021-11-04
• Study First Posted: 2021-11-16
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

1. 18+years old;
2. Masters of Art degree or higher in social/biomedical(medicine)/physical science, engineering or mathematics
3. current elevated distress as measured by the Depression Anxiety and Stress Scale, 21 item version(≥ 5 on DASS Depression Subscale OR ≥ 4 on DASS Anxiety Subscale OR ≥ 8 on DASS Stress Subscale) (DASS, Lovibond & Lovibond, 1995); and, (5) ≥ 5 on any subscale of the Sheehan Disability Scale (SDS, Sheehan 1983).

Exclusion Criteria

1. Any current or recent (i.e. past month) suicide ideation
2. any history of suicide attempt (within past 5 years)
3. serious mental illness (i.e., psychosis, mania)
4. alcohol or substance dependency during the past 6 months
5. serious medical problems (e.g., seizures, cancer)
6. current participation in psychotherapy
7. new use of psychoactive medications (i.e., benzodiazepines for less than 1 month or selective serotonin reuptake inhibitors [SSRIs], tricyclics, or serotonin-norepinephrine reuptake inhibitors [SNRIs] for less than 3 months).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
myCompass + Delayed Text Therapy Support	e-Health Treatment	Self-guided e-health treatment with delayed (44min) text support from a therapist.
myCompass Only	e-Health Treatment	Self-guided e-health treatment
myCompass + Delayed Video Therapy Support	e-Health Treatment	Self-guided e-health treatment with delayed (44min) video support from a therapist.

Primary Outcome Measures

Name	Time	Method
Functional impairment in work/school, social life, and family life change	Change from baseline at 6-weeks assessments, 1-weeks post treatment, and 1-month post treatment	Sheehan Disability Scale is a 3 item measure to assess functional impairment in work/school, social life, and family life.
Symptoms of Depression, Stress, and Anxiety Change	Change from baseline at 6-weeks assessments, 1-week post treatment, and 1-month post treatment	Depression Anxiety and Stress Scale is a 21-item measure to assess the severity of Depression, Stress, and Anxiety.

Secondary Outcome Measures

Name	Time	Method
Sleep Quality Change	Change from baseline at 1-week post treatment and 1-month post treatment	The Pittsburgh Sleep Quality Index (PSQI) is a 19-item questionnaire that assesses seven components of sleep quality (subjective sleep quality, sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction). Each component is rated on a 0-3 severity scale referring to the frequency of each disturbance, and yields a global score with a range of 0-21.
Fatigue Severity Change	Change from baseline at 1-week post treatment and 1-month post treatment	The Fatigue Severity Scale (FSS) measures fatigue and its effects on functioning. The FSS is comprised of nine items rated on a Likert-type rating scale (1-7), where one indicates no impairment and seven indicates severe impairment.
Treatment Satisfaction	1-week post treatment	The ARMS-12 measures confidence, comfortability, and perceptions towards the program. The ARMS-12 is comprised of 12 items rated on a Likert-type rating scale (1-7), where one indicates the how strongly the agree or disagree with the statement.

Trial Locations

Locations (1)

Mind-Body Clinical Research Center; 🇺🇸 Stony Brook, New York, United States